Nicox announces recruitment of last US patient in Denali Phase 3 trial of NCX 470

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Nicox SA announced the recruitment and randomization of the last patient in the US in its Denali Phase 3 trial of NCX 470.

The company noted that NCX 470 is a novel NO-donating bimatoprost eye drop currently in Phase 3 clinical development.

According to a news release, the Denali trial is evaluating NCX 470 safety and efficacy in patients with open-angle glaucoma or ocular hypertension and topline results continue to be expected in H2 2025, based on this completion of recruitment of patients in the U.S. and continuing good progress of the trial in China, where recruitment of patients is still ongoing. More than 95% of the total target number of patients have been randomized in this trial so far.¹

Doug Hubatsch, Chief Scientific Officer of Nicox, offered his thanks to patients, the clinical sites, the company’s internal team and investors for their efforts and support in enabling Nicox to reach this important milestone, the completion of US recruitment in the Denali trial.

“We will remain fully focused on NCX 470 and on continuing recruitment of patients in China to complete Denali as we move towards expected topline results in H2 2025,” he said in the news release.

The company noted its Denali trial is evaluating the intraocular pressure (IOP) lowering efficacy of once-daily dosed NCX 470 ophthalmic solution 0.1% compared to latanoprost ophthalmic solution 0.005% in patients with open-angle glaucoma or ocular hypertension.

The trial is a multi-country (U.S. and China) clinical trial financed equally by Nicox and Ocumension, Nicox’s exclusive licensee for China, Korea and Southeast Asia. The Denali trial, together with the Mont Blanc trial, was designed to fulfill the regulatory requirements to support New Drug Application (NDA) submissions of NCX 470 in the U.S. and China. The U.S. NDA for NCX 470 is expected to be submitted in H1 2026.¹

Topline results from the first Phase 3 trial, Mont Blanc, showed the IOP-lowering effect from baseline was 8.0 to 9.7 mmHg for NCX 470 vs. 7.1 to 9.4 mmHg for latanoprost. Statistical non-inferiority was met vs. latanoprost in the primary efficacy analysis and 4 out of 6 timepoints additionally demonstrated superiority; the trial therefore met the efficacy requirements for approval in the U.S. NCX 470 was well tolerated and discontinuation rates were low.¹

Reference:

1. SA N. Nicox Announces Recruitment of Last Patient in U.S. in Denali Phase 3 Trial of NCX 470. GlobeNewswire News Room. Published July 25, 2024. Accessed July 25, 2024. https://www.globenewswire.com/news-release/2024/07/25/2918501/0/en/Nicox-Announces-Recruitment-of-Last-Patient-in-U-S-in-Denali-Phase-3-Trial-of-NCX-470.html